This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice.
PRIMARY OBJECTIVES:
I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues.
II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries.
III. Assess the impact of PTeye on minimizing risk of post-surgical complications.
Participants will be randomized to either the experimental or control arm.
The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not.
For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Participants will be follow-ed up for up to 6 months after surgery.
Source: View full study details on ClinicalTrials.gov
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